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Prakash Mhatre

@prakashmhatre

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Quality Assurance leader in pharmaceuticals combining QA, RA and IT expertise.

India

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What I'm looking for

I am looking for a leadership role in QA/RA where I can drive cGMP compliance, improve QMS, lead audits, and support regulatory submissions while mentoring teams and leveraging IT tools for efficiency.

I am a pharmaceutical quality and regulatory professional with 17 years' experience driving cGMP compliance, regulatory submissions, and QMS optimization across API and formulation operations. I blend hands-on QA and RA expertise with strong IT skills including eCTD publishing, SAP, and Master Control.

I have led cross-functional teams to deliver timely project releases, manage validations (process, cleaning, equipment, computer systems), and implement CAPA strategies after vendor and internal audits. I routinely supported USFDA, CEP, ANDA submissions and coordinated with Qualified Persons for deviation and OOS resolution.

As an IRCA Certified ISO Lead Auditor and ZED Facilitator, I have executed risk-based vendor audits, GAP assessments, and training programs to maintain audit-ready documentation and robust data integrity. I have managed license acquisitions and regulatory interactions for multiple markets including ANVISA and other ROW agencies.

I seek to apply my compliance leadership, audit experience, and technical proficiency to improve product quality and operational efficiency in a forward-looking healthcare or pharma-technology organization.

Experience

Work history, roles, and key accomplishments

Consultant Quality Assurance

Crescent Pharma Limited

Dec 2021 - Nov 2023 (1 year 11 months)

Reviewed QMS documentation for CMOs, led SOP revisions and training, coordinated with UK QPs on deviations/OOS and audits, and provided CAPA recommendations to strengthen controls.

CAPA Internal Audit

Manager Quality Assurance

Great Pacific Exports Pvt. Ltd

Apr 2019 - Dec 2021 (2 years 8 months)

Led QA initiatives to ensure cGMP compliance, managed cleaning validations, SOPs, stability data and CAPA strategies, and represented the company in FDA and customer audits to improve product quality and operational efficiency.

CAPA SAP Data Integrity

Manager QA & RA

Aarambh Pharma

May 2018 - Mar 2019 (10 months)

Led DMF reviews and conducted audit gap assessments, delivered CAPA plans, validated documentation and Excel artifacts, and supported regulatory documentation services to drive compliance and business expansion.

CAPA Regulatory Risk Assessment

Senior Executive RA

Thinq Pharma-CRO Ltd.

Apr 2015 - May 2018 (3 years 1 month)

Managed regulatory submissions via eCTD/PHARMAREADY, conducted ~40 vendor audits, performed GAP assessments for 20+ companies, and prepared documents for USFDA, CEP and ANDA submissions.

PHARMAREADY Regulatory Submissions CAPA PharmaReady

Senior Executive QA & RA

Eskay Speciality Chemicals

Nov 2013 - Mar 2015 (1 year 4 months)

Led QA and regulatory strategies across group entities, maintained dossiers for global markets, coordinated license acquisitions (GMP/WHO-GMP/FSSAI), and ensured product compliance for export regions.

Regulatory Affairs GMP Licensing Artwork Review Vendor Management CAPA

JR. Executive QA

Elder Pharma Ltd

Nov 2011 - Oct 2013 (1 year 11 months)

Led validation protocol creation for tablets, capsules, creams and liquids, managed change control and deviation processes, and resolved market complaints to ensure regulatory adherence.

Change Control Deviation Management Market Complaint Resolution Batch Record Review Training

QA Officer

Watson Pharmaceutical Pvt Ltd

Mar 2011 - Nov 2011 (8 months)

Led annual product reviews, executed line clearance and process validation protocols, audited batch and cleaning records, and enforced CAPA using SAP QA32 to maintain product quality.

Annual Product Review Line Clearance Batch Record Review CAPA

JR. Executive QA

RPG Life Science Limited

Sep 2010 - Mar 2011 (6 months)

Compiled annual product reviews, issued and reviewed BMR/ECR, and participated in critical audits including MHRA and EDQM to uphold stringent quality benchmarks.

BMR ECR Review Annual Product Review MHRA EDQM Audit Support QA32 Gap Analysis

QA Chemist

Great Pacific Exports Pvt. Ltd

Jul 2008 - Sep 2010 (2 years 2 months)

Conducted sampling and analytical testing of raw materials and products, managed stability studies and SOP documentation, and supported GMP and customer audits to ensure quality compliance.

Analytical Testing (HPLC Karl Fischer SOP Management

Education

Degrees, certifications, and relevant coursework

K. J. Somaiya College

Master of Science, Organic Chemistry

2023 - 2025

Master of Science in Organic Chemistry pursued at K. J. Somaiya College between Nov 2023 and Sep 2025 focusing on advanced theoretical and practical aspects of synthetic methodologies and spectroscopic techniques.